Quality Healthcare Supervisor

FedExMemphis, TN
5d

About The Position

The Quality Healthcare Supervisor oversees internal quality systems and procedures related to the compliant and efficient packaging of drug substances and drug products. This role ensures product safety, quality, and legality while supporting site and network-level safety programs and maintaining inspection readiness in alignment with customer and regulatory standards.

Requirements

  • Bachelor’s degree or equivalent in a related field.
  • Minimum of three (3) years of experience in a quality and/or compliance role.
  • Ability to follow policies and procedures.
  • Ability to read, write, and interpret information.
  • Ability to add, subtract, multiply, and divide.
  • Ability to use hands to finger, handle, or feel.
  • Ability to sit, walk, or stand for the duration of the shift.
  • Must possess visual acuity to perform essential job functions.
  • Ability to conduct physical tasks with a full range of motion throughout the warehouse environment.
  • Ability to lift/carry items up to 50 pounds.

Nice To Haves

  • Validation experience (IQ/OQ/PQ) preferred.
  • Knowledge of healthcare regulations and FDA requirements preferred.
  • Experience with ISO standards preferred.
  • Certified Internal Auditor (CIA) or auditing experience preferred.
  • ASQ quality certification preferred.
  • Combination of office and on-site work required; travel within North America may be necessary.

Responsibilities

  • Oversee quality functions for display and packaging operations, including batch record review, FDA-regulated labeling, and inspections.
  • Manage Quality Investigation Reports (QIRs), including root cause analysis, CAPAs, and change controls.
  • Conduct periodic product reviews and manage consumer complaints.
  • Identify and address QMS gaps; provide compliance guidance for promotional packaging and labeling.
  • Support customer product recall and quality hold processes through product traceability and documentation.
  • Ensure inspection readiness and compliance with customer QMS standards.
  • Propose actions to maintain acceptable quality standards and minimize risk.
  • Facilitate use of unreleased product in packaging operations with customer approval.
  • Support quality objectives, metrics, and strategic initiatives defined by the customer and company.
  • Act as liaison with customer supply planners and internal stakeholders.
  • Lead internal Level I audits and SOP reviews per local auditing procedures.
  • Provide training to the Quality Department and general facility staff as a subject matter expert.
  • Support continuous improvement initiatives using Operational Excellence principles.
  • Implement and maintain the company’s Safety Management System; lead site Safety Committee.
  • Demonstrate advanced knowledge of FDA standards, GMPs, and quality systems.
  • Adapt quickly to changing business needs while managing multiple projects and deadlines.

Benefits

  • Competitive Pay: Competitive wages depending on your location and experience, paid bi-weekly for both full-time and part-time opportunities.
  • Tuition reimbursement program
  • Holiday pay and accrued paid time off programs offering both Vacation and PTO
  • Medical, dental, vision, and voluntary benefits available on day one
  • Basic life insurance
  • Basic AD&D coverage
  • Supplemental Life and Supplemental AD&D
  • Short-Term and Long-Term Disability coverage for full-time employees after 180 days of service
  • Paid parental leave for both moms and dads
  • Paid bereavement and jury duty
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